Overview

This trial is active, not recruiting.

Conditions poliomyelitis, diphtheria, haemophilus influenzae type b, tetanus, acellular pertussis, hepatitis b
Treatments infanrix hexa, pediarix, acthib, pentacel, engerix-b, infanrix, hiberix, prevnar13, rotarix
Phase phase 3
Sponsor GlaxoSmithKline
Start date April 2014
End date February 2015
Trial size 585 participants
Trial identifier NCT02096263, 117119

Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

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 in this group will receive 3 doses of Infanrix hexa (lot A) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
infanrix hexa
3 doses administered intramuscularly in the right thigh.
infanrix
1 dose administered intramuscularly in the right thigh
hiberix
1 dose administered intramuscularly in the left thigh
prevnar13
3 doses administered intramuscularly in the lower left thigh
rotarix
2 doses administered orally
(Experimental)
Subjects in this group will receive 3 doses of Infanrix hexa (lot B) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
infanrix hexa
3 doses administered intramuscularly in the right thigh.
infanrix
1 dose administered intramuscularly in the right thigh
hiberix
1 dose administered intramuscularly in the left thigh
prevnar13
3 doses administered intramuscularly in the lower left thigh
rotarix
2 doses administered orally
(Experimental)
Subjects in this group will receive 3 doses of Infanrix hexa (lot C) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
infanrix hexa
3 doses administered intramuscularly in the right thigh.
infanrix
1 dose administered intramuscularly in the right thigh
hiberix
1 dose administered intramuscularly in the left thigh
prevnar13
3 doses administered intramuscularly in the lower left thigh
rotarix
2 doses administered orally
(Experimental)
Subjects in this group will receive 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and ActHIB vaccines at 15-18 months of age
pediarix
3 doses administered intramuscularly in the right thigh
acthib
4 doses administered intramuscularly in the upper left thigh
infanrix
1 dose administered intramuscularly in the right thigh
prevnar13
3 doses administered intramuscularly in the lower left thigh
rotarix
2 doses administered orally
(Active Comparator)
Subjects in this group will receive 3 doses of Pentacel and Engerix-B* co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. *Subjects in the Penta Group who have received a dose of hepatitis B vaccine from birth up to 30 days prior to study vaccination should not receive Engerix-B at 4 months of age (Visit 2). Subjects will receive a booster dose of Pentacel vaccine at 15-18 months of age.
pentacel
4 doses administered intramuscularly in the right thigh
engerix-b
2 or 3 doses administered intramuscularly in the upper left thigh
prevnar13
3 doses administered intramuscularly in the lower left thigh
rotarix
2 doses administered orally

Primary Outcomes

Measure
Evaluation of immunogenicity with respect to pertussis components of the study vaccines Infanrix hexa and Pediarix
time frame: 1 month after the third dose of the primary vaccination (Month 7)

Secondary Outcomes

Measure
Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccines Infanrix hexa, Pentacel and Pediarix
time frame: 1 month after the third dose of the primary vaccination (Month 7)
Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccine Pentacel
time frame: 1 month after the third dose of the primary vaccination (Month 7)
Evaluation of immunogenicity with respect to the other components of the study vaccines Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B
time frame: 1 month after the third dose of the primary vaccination (Month 7)
Occurrence of solicited local and general symptoms
time frame: Within 4 days (Day 0 - Day 3) after each vaccination
Occurrence of unsolicited adverse events
time frame: Within 31 days (Day 0 - Day 30) after each vaccination
Occurrence of specific adverse events
time frame: From Day 0 up to 6 months post primary vaccination
Occurrence of Serious adverse events (SAEs)
time frame: From Day 0 up to 6 months post primary vaccination
Immunogenicity with respect to all study vaccines in terms of antibody concentration and titres
time frame: Before the booster dose (Dose 4) (Study month 13-16)
Immunogenicity with respect to the study vaccine Pentacel
time frame: 1 month after the booster dose (Dose 4) (Study month 14-17)
Immunogenicity with respect to the study vaccine Infanrix
time frame: 1 month after the booster dose (Dose 4) (Study month 14-17)
Immunogenicity with respect to the study vaccines ActHIB and Hiberix
time frame: 1 month after the booster dose (Dose 4) (Study month 14-17)
Occurence of solicited local and general symptoms
time frame: Within 4 days (Day 0 - Day 3) after booster vaccination (Infanrix, Hiberix, ActHIB and Pentacel)
Occurence of unsolicited adverse events
time frame: Within 31 days (Day 0 - Day 30) after booster vaccination
Occurence of specific adverse events
time frame: From the booster dose (Study month 13-16) up to 1 month after the booster vaccination (Study month 14-17)
Occurrence of SAEs
time frame: From the booster dose (Study month 13-16) up to 1 month after the booster vaccination (Study month 14-17)

Eligibility Criteria

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

Inclusion Criteria: - Subjects' parent(s)/ LAR(s) who, in the opinion of the investigator, 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. - Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks [259 to 293 days]). - Written informed consent obtained from parent(s)/LAR(s) of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - 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. Exclusion Criteria: - Child in care - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. - Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study: - Inactivated influenza and hepatitis A vaccines are allowed throughout the study. - Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US. - 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 (pharmaceutical product or device). - History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases. - Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. - 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 the vaccines (including yeast). - Hypersensitivity to latex. - Major congenital defects or serious chronic illness. - History of any neurological disorders including seizures. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. - History of Severe Combined Immunodeficiency Disease (SCID). - Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002. - Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Additional Information

Official title Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.