Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

GlaxoSmithKline500 enrolled

Overview

The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth: \- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Enrollment

500

Conditions

Diphtheria Hepatitis B Whole Cell Pertussis Haemophilus Influenzae Type b Tetanus

Interventions

Tritanrix-HepB/Meningitec conjugate vaccineBIOLOGICAL

The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

Tritanrix/Hiberix vaccineBIOLOGICAL

The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Eligibility

Sex: ALLMax age: 3 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria at study entry: * Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria at study entry: * Any confirmed immunodeficient condition, based on medical history \& physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Acute disease at the time of enrolment.

Locations (1)

GSK Investigational Site

City of Muntinlupa, Philippines

Outcomes

Primary Outcomes

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

Time frame: Days 0-3 post dose 1

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

Time frame: Days 0-3 post dose 2

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

Time frame: Days 0-3 post dose 3

Secondary Outcomes

Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose

Time frame: Days 0-3 after each dose

Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose

Time frame: Day 0-30 after each dose

Occurrence of serious adverse events during the entire study period

Time frame: Day 0 up to Month 5

Data from ClinicalTrials.gov

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