Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

Launched by GLAXOSMITHKLINE · Aug 5, 2008

Keywords

ClinConnect Summary

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
• • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• • Written informed consent obtained from the parents or guardians of the subject.
• • Born after a normal gestation period (between 36 and 42 weeks).
• Exclusion Criteria:
• • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
• • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
• • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
• • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
• • Use of antibiotics within 7 days preceding dose 1.
• • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
• • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
• • Acute disease at time of enrollment.
• • Gastroenteritis within 7 days preceding the study vaccine administration.
• • Household contact with an immunosuppressed individual or pregnant women.
• • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
• • Previous confirmed occurrence of rotavirus gastroenteritis.
• • Inability to contact parents/guardians of the subject by telephone.