Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01353703
• Date of registration: 12/05/2011
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
• Scientific title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
• Date of first enrolment: May 2012
• Target sample size: 224
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01353703
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

India

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 6 Weeks
Age maximum: 10 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Diphtheria

Haemophilus Influenzae Type b Disease

Hepatitis B

Pertussis

Poliomyelitis

Tetanus

Intervention(s)

Biological: Infanrix hexa™

Primary Outcome(s)

Immunogenicity with respect to components of the study vaccine, in terms of number of seroprotected subjects [Time Frame: One month after the third dose of primary vaccination, i.e. at the age of 18 weeks or 7 months]

Secondary Outcome(s)

Immunogenicity with respect to components of the study vaccine in terms of antibody titres [Time Frame: Before the first dose of primary vaccination (Day 0) and one month after the third dose of primary vaccination, i.e. at the age of 18 weeks or 7 months]

Occurrence of serious adverse events [Time Frame: From Dose 1 (Day 0) up to study end i.e. at the age of 18 weeks or 7 months]

Occurrence of solicited local and general symptoms [Time Frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination]

Occurrence of unsolicited adverse events [Time Frame: During the 31-day (Day 0-Day 30) follow-up period after each vaccination]

Secondary ID(s)

111157

Source(s) of Monetary Support

Please refer to primary and secondary sponsors