Meningococcal

Trumenba by Pfizer (Meningococcal B)

Captured 2022-12-06

Document Highlights

Initial U.S. Approval: 2014

Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B… approved for use in individuals 10 through 25 years of age.

Serious Adverse Events
SAEs were reported by… 1.6% subjects… who received at least one dose of Trumenba…

Non-serious Adverse Events
AEs that occurred within 30 days of vaccination were reported in… 30.6% subjects who received at least one dose of Trumenba…

Postmarketing Experience
Hypersensitivity reactions, including anaphylactic reactions.
Syncope (fainting).

Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.

Each 0.5 mL dose contains… 0.25 mg of Al3+ [aluminum] as AlPO4 [aluminum phosphate]…

Trumenba has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males.

Comments

Two out of nine controlled Trumenba clinical trials administered saline as the placebo.

"The safety of Trumenba was evaluated in 16,284 subjects... in 12 clinical studies (9 randomized controlled and 3 supportive non-controlled studies)..."

"A total of 5,501 subjects... in the control groups received saline placebo and/or one of the following vaccine(s)... HPV4... Tdap... MenACWY... dTaP-IPV... HAV [Hepatitis A vaccine]..."

"Study 1009 was a randomized, active-controlled... trial... in which 2,693 subjects... received at least 1 dose of Trumenba on a 0-, 2-, and 6- month schedule. A control group (n=897) received HAV [Hepatitis A vaccine] at 0 and 6 months, and saline at 2 months."

Safety data are obscured in the above trial due to Hepatitis A vaccine being administered to control group subjects two months prior and 4 months later.

"Study 1016 was a randomized, placebo-controlled... trial... in which 2,471 subjects... received at least 1 dose of Trumenba and 822 subjects received saline on a 0-, 2,- and 6- month schedule."

Tables 2, 3, 4, and 5 in the package insert provide more detail comparing adverse reactions.

The data from 8 clinical trial control groups (most using active comparators, i.e. other vaccines) were combined with data from the two trials above which included saline injections, to determine the rate at which serious adverse events occurred in control group subjects.

Why placebo controlled trials are necessary.

Vaccine.Guide

Trumenba by Pfizer (Meningococcal B)