Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345579

Enrollment

4432

Registered

2006-06-28

Start date

2006-09-30

Completion date

2008-03-31

Last updated

2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Influenzae Type b, Neisseria Meningitidis

Keywords

Prophylaxis, Neisseria meningitidis Vaccines, conjugate, Infants, Meningococcal vaccines, H. influenzae type B vaccine, Humans, Safety

Brief summary

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Detailed description

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Interventions

BIOLOGICALGSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014

3-dose intramuscular injection

BIOLOGICALActHIB

3-dose intramuscular injection

BIOLOGICALPediarix/Infanrix Penta

3-dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after 36 weeks gestation. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. * Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. * In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar. * History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at time of enrollment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reporting Serious Adverse Events (SAEs)	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Rash	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)	Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)	—
Number of Subjects With Serious Adverse Events (SAEs)	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Rash	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)	Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Number of Subjects With Adverse Events Resulting in Emergency Room (ER)	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)	—

Countries

Mexico, United States

Participant flow

Recruitment details

This summary presents results for the primary vaccination phase up to the end of the extended safety follow-up (until, but excluding, the booster dose at 12-15 months of age). For results about the booster/fourth dose phase, see study NCT00345683.

Pre-assignment details

Of the 4432 subjects enrolled, 4391 were vaccinated and 4162 completed the primary vaccination phase of the study (3114 in the MenHibrix Group and 1048 in the ActHIB Group).

Participants by arm

Arm	Count
MenHibrix Group Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	3,278
ActHIB Group Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	1,113
Total	4,391

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	9	6
Overall Study	Lost to Follow-up	82	36
Overall Study	Other	9	1
Overall Study	Protocol Violation	14	5
Overall Study	Withdrawal by Subject	50	17

Baseline characteristics

Characteristic	MenHibrix Group	ActHIB Group	Total
Age, Continuous	58.6 Days STANDARD_DEVIATION 10.45	59.0 Days STANDARD_DEVIATION 10.39	58.8 Days STANDARD_DEVIATION 10.42
Gender Female	1576 Participants	557 Participants	2133 Participants
Gender Male	1702 Participants	556 Participants	2258 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	157 / 3,278	48 / 1,113