CompletedNCT00729001Updated Sep 16, 2016

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

A Phase 2 interventional study of Human Rotavirus Vaccine - two different formulations and Prevnar in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 529
Allocation: Randomized
Ages: 6 Weeks to 12 Weeks
Sex: All

Study summary

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Read the detailed description

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.

Conditions studied

Infections, Rotavirus

Browse trials for

Rotavirus Infections 101

Keywords

Rotavirus Gastroenteritis
Human rotavirus vaccine

In context

Rotavirus Infections

101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 529 is above the median of 402 across 68 interventional studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 12 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 529 participants (actual)

Study arms

Experimental
Group A
Human Rotavirus Vaccine - Formulation 1
Biological: Human Rotavirus Vaccine - two different formulations · Biological: Prevnar · Biological: IPOL · Biological: Infanrix · Biological: OmniHIB · Biological: Pentacel
Experimental
Group B
Human Rotavirus Vaccine - Formulation 2
Biological: Human Rotavirus Vaccine - two different formulations · Biological: Prevnar · Biological: IPOL · Biological: Infanrix · Biological: OmniHIB · Biological: Pentacel
Placebo comparator
Group C
Biological: Prevnar · Biological: IPOL · Biological: Infanrix · Biological: OmniHIB · Biological: Pentacel

Interventions

BiologicalHuman Rotavirus Vaccine - two different formulations
Two oral doses
BiologicalPrevnar
Three-dose intramuscular injection (US subjects only)
BiologicalIPOL
Two-dose intramuscular injection (US subjects only)
BiologicalInfanrix
Three-dose intramuscular injection (US subjects only)
BiologicalOmniHIB
Three-dose intramuscular injection (US subjects only)
Also known as: ActHIB
BiologicalPentacel
Three-dose intramuscular injection (Canada only)

What researchers measure

Primary outcomes

Proportion of subjects with vaccine take
Time frame: Two months after the second dose
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.

Secondary outcomes

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 unsolicited symptoms according to WHO classification.
Time frame: Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Time frame: Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
Time frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Time frame: Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
Time frame: 2 months after dose 1
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.
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)
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.
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.
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.

Study locations

No study locations are listed for this record.

References and documents

Publications

Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1. PubMed 16111790 ↗
Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71. PubMed 15933555 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00729001
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Aug 6, 2008
Start date: Nov 2000
Primary completion: Sep 2002
Completion: Sep 2002
Last update: Sep 16, 2016

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rotavirus Infections→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion