Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00290342
• Date of registration: 10/02/2006
• Primary sponsor: GlaxoSmithKline
• Public title: Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
• Scientific title: A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. Co-administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children
• Date of first enrolment: January 2006
• Target sample size: 452
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00290342
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Korea, Republic of

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Subjects who the investigator believes that their parents/guardians can and will
comply with the requirements of the protocol .

- A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the
time of the first vaccination.

- Written informed consent obtained from the parent or guardian of the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first
dose of the study vaccine.

- Planned administration/ administration of a vaccine not foreseen by the study
protocol during the study period (i.e. Day 0 to Month 7), with the exception of
Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu
vaccine and Hib vaccine.

- Planned administration/ administration of a vaccine foreseen by the study protocol
(i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine)
during the period 30 days before and one week after the study vaccine dose.

- 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).

- Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus
disease.

- History of diphtheria, tetanus, pertussis and/or poliovirus diseases.

- Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study
period.

- Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from
intramuscular injection.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine(s).

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at the time of enrolment

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.



Age minimum: 8 Weeks
Age maximum: 12 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Diphtheria, Tetanus, Pertussis, Poliomyelitis

Intervention(s)

Biological: DTPa

Biological: DTPa-IPV

Biological: IMOVAX Polio®

Primary Outcome(s)

Anti- poliovirus type 2 titre [Time Frame: One month after the three-dose primary vaccination course]

Anti- poliovirus type 3 titre [Time Frame: One month after the three-dose primary vaccination course]

Anti-diphtheria antibody concentration [Time Frame: One month after the three-dose primary vaccination course]

Anti-pertussis antibody concentrations [Time Frame: One month after the three-dose primary vaccination course]

Anti-poliovirus type 1 titre [Time Frame: One month after the three-dose primary vaccination course]

Anti-tetanus antibody concentration [Time Frame: One month after the three-dose primary vaccination course]

Vaccine response to pertussis antigens [Time Frame: One month after the three-dose primary vaccination course]

Secondary Outcome(s)

Geometric mean concentration or titre of antibodies for all vaccine antigens [Time Frame: Before and one month after the three-dose primary vaccination course]

Occurrence of serious adverse events. [Time Frame: During the entire study period]

Occurrence of solicited general adverse events [Time Frame: During the 4 day follow-up period after vaccination.]

Occurrence of solicited local adverse events [Time Frame: During the 4 day follow-up period after vaccination]

Occurrence of unsolicited local and general adverse events [Time Frame: During the 31-day follow-up period after vaccination]

Secondary ID(s)

104871

Source(s) of Monetary Support

Please refer to primary and secondary sponsors