Clinical trial NCT01353703: Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Tetanus
Acellular Pertussis
Haemophilus Influenzae Type b
Diphtheria
Hepatitis B
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Keywords: Infanrix hexa™
Primary vaccination
India
combination vaccine
infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 224
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Seroprotected Subjects Against Hepatitis B (HBs)
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
timeFrame: One month post Dose 3 (Month 3 or Month 5)
Secondary outcomes:
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Anti-HBs Antibody Concentrations
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Anti-Polio Types 1, 2, 3 Antibody Titers
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Anti-PRP Antibody Concentrations
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: One month post Dose 3 (Month 3 or Month 5)
measure: Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
timeFrame: At Month 0
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
timeFrame: At Month 0
measure: Number of Seroprotected Subjects Against Anti-HBs Antigens
timeFrame: At Month 0
measure: Anti-Polio Types 1, 2 and 3 Antibody Titers
timeFrame: At Month 0
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: At Month 0
measure: Anti-HBs Antibody Concentrations
timeFrame: At Month 0
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))
Other outcomes:
Locations:
city: Belgaun
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.