Imovax Meningo A + C

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Imovax Meningo A + C uses

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• References
• How supplied/storage and handling
• Patient counseling information
• Imovax Meningo A + C reviews

1 INDICATIONS AND USAGE

Imovax Meningo A + C is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Imovax Meningo A + C is approved for use in individuals 10 through 25 years of age.

The effectiveness of the two-dose schedule of Imovax Meningo A + C against diverse N. meningitidis serogroup B strains has not been confirmed.

• Imovax Meningo A + C is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Imovax Meningo A + C is approved for use in individuals 10 through 25 years of age. (1)
• The effectiveness of the two-dose schedule of Imovax Meningo A + C against diverse N. meningitidis serogroup B strains has not been confirmed. (1)

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

• For intramuscular use only.
• Three-dose schedule: Administer a dose (0.5 mL) at 0, 1–2, and 6 months. (2.1)
• Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months. If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose. (2.1)

2.1 Dose and Schedule

Three-dose schedule: Administer a dose (0.5 mL) at 0, 1–2, and 6 months.

Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months. If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose.

The choice of dosing schedule may depend on the risk of exposure and the patient's susceptibility to Imovax Meningo A + C serogroup B disease.

2.2 Administration

Shake syringe vigorously to ensure that a homogenous white suspension of Imovax Meningo A + C is obtained. Do not use the vaccine if it cannot be re-suspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.

Inject each 0.5 mL dose intramuscularly, using a sterile needle attached to the supplied prefilled syringe. The preferred site for injection is the deltoid muscle of the upper arm. Do not mix Imovax Meningo A + C with any other vaccine in the same syringe.

2.3 Use of Imovax Meningo A + C with other Imovax Meningo A + C Group B Vaccines

Sufficient data are not available on the safety and effectiveness of using Imovax Meningo A + C and other Imovax Meningo A + C group B vaccines interchangeably to complete the vaccination series.

3 DOSAGE FORMS AND STRENGTHS

Imovax Meningo A + C is a suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe.

• Suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3)

4 CONTRAINDICATIONS

Severe allergic reaction after a previous dose of Imovax Meningo A + C.

• Severe allergic reaction after a previous dose of Imovax Meningo A + C. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Management of Allergic Reactions

Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Imovax Meningo A + C.

5.2 Altered Immunocompetence

Individuals with altered immunocompetence may have reduced immune responses to Imovax Meningo A + C.

5.3 Limitation of Vaccine Effectiveness

As with any vaccine, vaccination with Imovax Meningo A + C may not protect all vaccine recipients against N. meningitidis serogroup B infections.

6 ADVERSE REACTIONS

In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at the injection site, fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). Nausea was reported in up to 24% of adolescents in early phase studies.

The most common solicited adverse reactions in adolescents and young adults were pain at the injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice.

The safety of Imovax Meningo A + C was evaluated in 15,227 subjects 10 through 25 years of age in 11 clinical studies (8 randomized controlled and 3 supportive non-controlled studies) conducted in the U.S., Europe, Canada, Chile, and Australia. A total of 11,333 adolescents (10 through 18 years of age) and 3,894 adults (19 through 25 years of age) received at least one dose of Imovax Meningo A + C. A total of 5,501 subjects 10 through 25 years of age in the control groups received saline placebo and/or one of the following vaccine(s): Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co., Inc.); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.); Imovax Meningo A + C Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.); a non-U.S. licensed reduced diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated polio virus vaccine (dTaP-IPV) (Sanofi Pasteur, Inc.); Hepatitis A Vaccine, Inactivated (HAV) (GlaxoSmithKline Biologicals).

The safety evaluation in the clinical studies included an assessment of: (1) solicited local and systemic reactions, and use of antipyretic medication after each vaccination in an electronic diary maintained by the subject or the subject's parent/legal guardian and (2) spontaneous reports of adverse events (AEs), including serious adverse events (SAEs), throughout the study (day of vaccination through one month or 6 months after the last vaccination, depending on the study and safety parameter).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among subjects who received Imovax Meningo A + C and those who received control. Overall, across the 11 studies, among the subjects who received Imovax Meningo A + C, 50.5% were male and 49.5% were female, and the majority were White (86.3%) and non-Hispanic/non-Latino (87.3%).

Solicited Local and Systemic Adverse Reactions

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,693 subjects 10 to 18 years of age received at least 1 dose of Imovax Meningo A + C on a 0-, 2-, and 6- month schedule. A control group (n=897) received HAV at 0 and 6 months and saline at 2 months. 87.3% of subjects were White, 8.1% were Black or African-American, 0.4% were Asian, and 5.8% were Hispanic or Latino. Overall, 51.5% of subjects were male, 55.6% of participants were 10 to 14 years age, and 44.4% were 15 to 18 years of age.

Study 2 was a Phase 3, randomized, placebo-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,471 subjects 18 to 25 years of age received at least 1 dose of Imovax Meningo A + C and 822 subjects received saline on a 0-, 2,- and 6- month schedule. 76.1% of subjects were White, 20.8% were Black or African-American, 1.6% were Asian, and 17.1% were Hispanic or Latino. Overall, 41.3% of subjects were male.

Local adverse reactions at the Imovax Meningo A + C injection site and control (HAV/saline or saline) injection site were assessed in both studies.

Tables 1 and 2 present the percentage and severity of reported local adverse reactions within 7 days following each dose of Imovax Meningo A + C or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

Local adverse reactions were reported more frequently following Imovax Meningo A + C compared to control.

In Study 1, mean duration of pain was 2.4 to 2.6 days (range 1–17 days), for redness 2.0 to 2.2 days (range 1–12 days) and for swelling 2.0 to 2.1 days (range 1–21 days) in the combined Imovax Meningo A + C group. In Study 2, mean duration of pain was 2.6 to 2.8 days (range 1–67 days), for redness 2.2 to 2.5 days (range 1–13 days) and for swelling 2.1 to 2.6 days (range 1–70 days) in the Imovax Meningo A + C group.

Tables 3 and 4 present the percentage and severity of reported solicited systemic adverse reactions within 7 days of each dose of Imovax Meningo A + C or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

The frequencies of adverse reactions were highest after the first dose regardless of the schedule. After subsequent doses, the frequencies of adverse reactions were similar regardless of dose number and schedule.

Serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received at least one dose of Imovax Meningo A + C, serious adverse events (SAEs) were reported by 269 (1.8%) subjects.

Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), SAEs were reported by 213 (1.6%) subjects and by 106 (1.9%) subjects who received at least one dose of Imovax Meningo A + C or control, respectively.

Non-serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received Imovax Meningo A + C, non-serious AEs within 30 days after any dose were reported in 4,463 (29.3%) subjects. Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), AEs that occurred within 30 days of vaccination were reported in 4,056 (30.6%) subjects who received Imovax Meningo A + C and 1,539 (28.0%) subjects in the control group, for individuals who received at least one dose. AEs that occurred at a frequency of at least 2% and were more frequently observed in subjects who received Imovax Meningo A + C than subjects in the control group were injection site pain, fever, and headache.

6.2 Postmarketing Experience

The following is considered an adverse reaction for Imovax Meningo A + C and was reported in the postmarketing experience. Because this reaction was derived from spontaneous reports, the frequency could not be determined.

Immune System Disorders: Hypersensitivity reactions, including anaphylactic reactions.

7 DRUG INTERACTIONS

In clinical trials, Imovax Meningo A + C was administered concomitantly with HPV4 in adolescents 11 to <18 years of age and with MCV4 and Tdap in adolescents 10 to <13 years of age .

8 USE IN SPECIFIC POPULATIONS

• Pediatric Use: Safety and effectiveness have not been established in children <10 years of age. In a clinical study, 90% of infants <12 months of age who were vaccinated with a reduced dosage formulation had fever.

8.1 Pregnancy

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of Imovax Meningo A + C in pregnant women. Available human data on Imovax Meningo A + C administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Two developmental toxicity studies were performed in female rabbits administered Imovax Meningo A + C prior to mating and during gestation. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). These studies revealed no evidence of harm to the fetus or offspring (until weaning) due to Imovax Meningo A + C.

Animal Data

Two developmental toxicity studies were performed in female rabbits. Animals were administered Imovax Meningo A + C by intramuscular injection 17 days and 4 days prior to mating and on gestation Days 10 and 24. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). No adverse effects on pre-weaning development up to post-natal day 21 were observed. There were no fetal malformations or variations observed due to the vaccine.

8.2 Lactation

Risk Summary

Available data are not sufficient to assess the effects of Imovax Meningo A + C on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Imovax Meningo A + C and any potential adverse effects on the breastfed child from Imovax Meningo A + C or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

8.4 Pediatric Use

Safety and effectiveness have not been established in children <10 years of age. In a clinical study, 90% of infants <12 months of age who were vaccinated with a reduced dosage formulation had fever.

8.5 Geriatric Use

Safety and effectiveness of Imovax Meningo A + C in adults older than 65 years of age have not been established.

11 DESCRIPTION

Imovax Meningo A + C is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively).¹ The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.

Each 0.5 mL dose contains 60 micrograms of each fHBP variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³ ⁺ as AlPO₄ in 10 mM histidine buffered saline at pH 6.0.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Protection against invasive Imovax Meningo A + C disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis. The effectiveness of Imovax Meningo A + C was assessed by measuring serum bactericidal activity using human complement (hSBA).

fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B.¹ The susceptibility of serogroup B meningococci to complement-mediated antibody-dependent killing following vaccination with Imovax Meningo A + C is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.

13 NONCLINICAL TOXICOLOGY

Imovax Meningo A + C has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males. Vaccination of female rabbits with Imovax Meningo A + C had no effect on fertility .

14 CLINICAL STUDIES

The immunogenicity of Imovax Meningo A + C following the three-dose schedule was evaluated in individuals 10 to 25 years of age in the U.S., Canada, and Europe (Studies 1 and 2) and following the two-dose (0 and 6 months) and three-dose schedules (0, 1–2, and 6 months) in individuals 11 to 18 years of age in Europe (Study 3). Serum bactericidal antibodies were measured with hSBA assays that used each of four Imovax Meningo A + C serogroup B strains. These four primary test strains express fHBP variants representing the two subfamilies (A and B) and, when taken together, are representative of Imovax Meningo A + C serogroup B strains causing invasive disease in the U.S. and Europe. The studies assessed the proportions of subjects with a 4-fold or greater increase in hSBA titer for each of the four primary strains. The studies also assessed the composite response to the four primary strains combined (proportion of subjects who achieved a hSBA titer greater than or equal to 1:8 (three strains) or 1:16 (one strain). To assess the effectiveness of the three-dose schedule of Imovax Meningo A + C against diverse Imovax Meningo A + C serogroup B strains, the proportion of subjects achieving a defined hSBA titer post-dose 3 was evaluated against a panel of 10 additional strains, each expressing a different fHBP variant.

14.1 Immunogenicity

The hSBA responses to each of the primary strains observed in U.S. subjects after the third dose of Imovax Meningo A + C are presented for Study 1 and Study 2 in Table 5.

The hSBA responses against a panel of 10 additional strains observed in U.S. subjects after the third dose of Imovax Meningo A + C are presented for Study 1 and Study 2 in Table 6.

In Study 3, Imovax Meningo A + C was administered according to different schedules, including Group 1 (0, 1, and 6 months), Group 2 (0, 2, and 6 months) and Group 3 (0 and 6 months). The hSBA responses observed after the second dose in Groups 1, 2, and 3 and completion of the three-dose series in Group 1 and 2 are presented in Table 7.

14.2 Concomitant Vaccine Administration

Study 4 evaluated the immunogenicity of concomitantly administered Imovax Meningo A + C and Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co, Inc.). U.S. subjects 11 to <18 years of age were randomized into three groups: Group 1 received Imovax Meningo A + C and HPV4 (N=992), Group 2 received Imovax Meningo A + C and saline (N=990), and Group 3 received saline and HPV4 (N=501). All vaccines were administered according to a 0, 2 and 6 month schedule. Immune responses were evaluated by comparisons of geometric mean titer [GMT] for each HPV type at 1 month after the third HPV4 vaccination (Group 1 vs. Group 3), and hSBA GMTs using two Imovax Meningo A + C serogroup B strains [variants A22 and B24] 1 month after the third Imovax Meningo A + C vaccination (Group 1 vs. Group 2). The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (Group 1/Group 3 for HPV and Group 1/Group 2 for Imovax Meningo A + C serogroup B strains) >0.67] were met for three HPV types (6, 11 and 16) and for the Imovax Meningo A + C serogroup B strains tested. For HPV-18, the lower bound of the 95% CI for the GMT ratio was 0.62 at one month after the third HPV4 vaccination.

Study 5 evaluated the immunogenicity of concomitantly administered Imovax Meningo A + C and Imovax Meningo A + C Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.) vaccines. U.S. subjects 10 to <13 years of age were randomized into three groups: Group 1 received Imovax Meningo A + C at 0, 2, and 6 months, and MCV4 and Tdap were coadministered with the first Imovax Meningo A + C dose (N=883). Group 2 received saline at 0, 2 and 6 months, and MCV4 and Tdap were coadministered with the first saline injection (N=870). Group 3 received Imovax Meningo A + C at 0, 2 and 6 months, and saline was coadministered with the first Imovax Meningo A + C dose (N=875). Immune responses were evaluated by comparisons of GMTs for each of the MCV4 and Tdap antigens 1 month after the first Imovax Meningo A + C vaccination, and hSBA GMTs using two Imovax Meningo A + C serogroup B strains [variants A22 and B24] 1 month after the third Imovax Meningo A + C vaccination. The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% CI of the GMT ratio (Group 1/Group 3 for Imovax Meningo A + C serogroup B strains and Group 1/Group 2 for MCV4 and Tdap) >0.67] were met for all antigens.

15 REFERENCES

• Wang X, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the U.S. Vaccine 2011; 29:4739–4744.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Imovax Meningo A + C is supplied in the following strengths and package configurations:

Prefilled Syringe, 1 Dose – NDC 0005-0100-10.

Prefilled Syringe, 1 Dose (5 per package) – NDC 0005-0100-05.

After shipping, Imovax Meningo A + C may arrive at temperatures between 2°C to 25°C (36°F to 77°F).

The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

16.2 Storage and Handling

Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F).

Store syringes in the refrigerator horizontally (laying flat on the shelf) to minimize the re-dispersion time.

Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, the healthcare professional should inform the individual, parent, guardian, or other responsible adult of the following:

• The importance of completing the immunization series.
• Report any suspected adverse reactions to a healthcare professional.

Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

U.S. Govt. License No. 3

CPT Code 90621

LAB-0722-6.0

Logo

NDC 0005-0100-01

Rx only

Imovax Meningo A + C

Group B Vaccine

Imovax Meningo A + C ^®

One Dose (0.5 mL) FOR IM USE ONLY

REFRIGERATE

DO NOT FREEZE

SHAKE VIGOROUSLY

Wyeth Pharm. Inc

US Govt. License No. 3

Imovax Meningo A + C pharmaceutical active ingredients containing related brand and generic drugs:

• Meningococcal Vaccine

Imovax Meningo A + C available forms, composition, doses:

• N/A

Imovax Meningo A + C destination | category:

• Human:
• Vaccines, antisera and immunologicals

Imovax Meningo A + C Anatomical Therapeutic Chemical codes:

• J07AH - Meningococcal vaccines

Imovax Meningo A + C pharmaceutical companies:

• Sanofi-Aventis
• Zuoz Pharma

Frequently asked Questions

Depending on the reaction of the Imovax Meningo A + C after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Imovax Meningo A + C not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology