Overview

This trial is active, not recruiting.

Conditions tetanus, diphtheria, haemophilus influenzae type b, whole cell pertussis, hepatitis b
Treatments meningococcal vaccine gsk 134612, synflorixtm, infanrix-ipv/hiberixtm
Phase phase 3
Sponsor GlaxoSmithKline
Start date January 2012
End date August 2014
Trial size 753 participants
Trial identifier NCT01340898, 114858

Summary

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects who receive 3 primary doses and 1 booster dose of the investigational vaccine, (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age).
meningococcal vaccine gsk 134612
Intramuscular injection
synflorixtm
Intramuscular injection
infanrix-ipv/hiberixtm
Intramuscular injection
(Experimental)
Subjects who receive 1 primary dose and 1 booster dose of the investigational vaccine, (1 dose at 6 months of age followed by a booster dose at 15-18 months of age)
meningococcal vaccine gsk 134612
Intramuscular injection
synflorixtm
Intramuscular injection
infanrix-ipv/hiberixtm
Intramuscular injection
(Experimental)
Subjects who receive 1 dose of the investigational vaccine, at 15-18 months of age
meningococcal vaccine gsk 134612
Intramuscular injection
synflorixtm
Intramuscular injection
infanrix-ipv/hiberixtm
Intramuscular injection

Primary Outcomes

Measure
Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with a titer equal to or above the cut-off value
time frame: One month post-dose 3 (Month 5)

Secondary Outcomes

Measure
Immunogenicity with respect to components of the investigational vaccine in terms of number of subject with titers equal to or above cut-off values
time frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14)
Immunogenicity with respect to components of the co-administered vaccines in terms of number of subjects with concentrations equal to or above cut-off values
time frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14)
Number of subjects with solicited local and general symptoms
time frame: Within 8 days (Day0 to Day7) after each vaccine dose
Number of subjects with unsolicited adverse events
time frame: Within 31 days (Day 0 to 30) after each vaccine dose
Number of subjects with serious adverse events
time frame: Throughout the study period (Month 0 to Month 19)
Number of subjects with new onset of chronic illnesses
time frame: Throughout the study period (Month 0 to Month 19)
Immunogenicity with respect to components of the investigational vaccine in terms of antibody titers
time frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14)
Immunogenicity with respect to components of the investigational vaccine in terms of number of subjects with vaccine response
time frame: At Month 14
Immunogenicity with respect to components of the co-administered vaccines in terms of antibody concentrations
time frame: One month post-dose 3 (Month 5), prior to (Month 13) and one month-post booster (Month 14)

Eligibility Criteria

Male or female participants from 6 weeks up to 12 weeks old.

Inclusion Criteria: - Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. - A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Born after a gestation period of at least 36 weeks. Exclusion Criteria: - Child in care. - Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Extended administration of immunosuppressants or other immune-modifying drugs since birth. - Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine. - Concurrently participating 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. - Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia. - History of receipt of meningococcal vaccine. - Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine. - History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Family history of congenital or hereditary immunodeficiency. - History of any reaction or hypersensitivity likely to be exacerbated by any component of th

Additional Information

Official title Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Description This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.