Phase 3
N=224
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Poliomyelitis · Tetanus · Acellular Pertussis · Haemophilus Influenzae Type b · Diphtheria
Bottom Line
View on ClinicalTrials.gov: NCT01353703 ↗Enrolled (actual)
224
Serious AEs
2.2%
Results posted
Jan 2019
Primary outcome: Primary: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens — 105; 106; 105; 106 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Infanrix hexa™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens |
105; 106; 105; 106 | — |
| PRIMARY Number of Seroprotected Subjects Against Hepatitis B (HBs) |
101; 104 | — |
| PRIMARY Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens |
99; 99; 77; 88; 73; 79 | — |
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens |
104; 105 | — |
| PRIMARY Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) |
61; 67; 44; 36; 12; 12 | — |
| SECONDARY Anti-D and Anti-T Antibody Concentrations |
2.334; 3.726; 3.307; 4.904 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
5.9; 5.6 | — |
| SECONDARY Anti-Polio Types 1, 2, 3 Antibody Titers |
884.3; 1799.2; 840.2; 2138.7; 923.7; 2245.5 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
2.697; 5.404 | — |
| SECONDARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
5; 4.6; 18.7; 20.1; 3.4; 3.2 | — |
| SECONDARY Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN |
44; 37; 89; 90; 19; 15 | — |
| SECONDARY Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens |
71; 70; 38; 42; 23; 30 | — |
| SECONDARY Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN |
44; 37; 89; 90; 19; 15 | — |
| SECONDARY Number of Seroprotected Subjects Against Anti-HBs Antigens |
14; 13 | — |
| SECONDARY Anti-Polio Types 1, 2 and 3 Antibody Titers |
53.5; 31.9; 32.5; 36.2; 8; 11.9 | — |
| SECONDARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
5; 4.6; 18.7; 20.1; 3.4; 3.2 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
5.9; 5.6 | — |
| SECONDARY Number of Subjects With Any Solicited Local Symptoms |
23; 11; 3; 1; 7; 4 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
0; 2; 8; 5; 1; 3 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
40; 25 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 3 | — |
Summary
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Eligibility Criteria
Inclusion Criteria
All subjects must satisfy ALL the following criteria at study entry:
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
- Documented administration of a hepatitis B vaccine dose at birth
- Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- 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
The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
- Child in care
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
- 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
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Family history of congenital or hereditary immunodeficiency
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- Major congenital defects or serious chronic illness
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- Acute disease and/or fever at the time of enrolment
Data sourced from ClinicalTrials.gov (NCT01353703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.