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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00729001
• Date of registration: 04/08/2008
• Primary sponsor: GlaxoSmithKline
• Public title: Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
• Scientific title: Study of Two Doses of GlaxoSmithKline Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine (Two Different Formulations) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.
• Date of first enrolment: November 2000
• Target sample size: 529
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00729001
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Canada, Puerto Rico, United States

Contacts

• Name: Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 6 Weeks
Age maximum: 12 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Rotavirus Gastroenteritis

Intervention(s)

Biological: Human Rotavirus Vaccine - two different formulations

Biological: Infanrix

Biological: IPOL

Biological: OmniHIB

Biological: Pentacel

Biological: Placebo

Biological: Prevnar

Primary Outcome(s)

Occurrence of any grade 2 or 3 fever, vomiting or diarrhea [Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine.]

Proportion of subjects with vaccine take [Time Frame: Two months after the second dose]

Secondary Outcome(s)

Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations [Time Frame: Two months after dose 2 and at the end of the study.]

Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status. [Time Frame: Two months after dose 2 and at the end of the study.]

Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status. [Time Frame: Two months after dose 2 and at the end of the study.]

Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [Time Frame: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)]

Occurrence of each type of solicited symptoms [Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine]

Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects) [Time Frame: Two weeks after dose 2 until the end of the rotavirus season following vaccination.]

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

Occurrence of unsolicited symptoms according to WHO classification. [Time Frame: Within 42 days after dose 1 and dose 2]

Rotavirus seropositivity status [Time Frame: Before dose 1 and at the end of the study]

Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants [Time Frame: Two months after dose 2.]

Serum rotavirus immunoglobulin A (IgA) antibody titers [Time Frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset]

Vaccine take (for pilot efficacy subset only) [Time Frame: 2 months after dose 1]

Secondary ID(s)

444563/005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors