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Infections, RotavirusPhase 2NCT00729001

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

A Phase 2 study testing Human Rotavirus Vaccine - two different formulations, Prevnar and IPOL in people with Infections, Rotavirus, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus
What is being tested?
Human Rotavirus Vaccine - two different formulations, Prevnar and IPOL
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
529 participants
Where
No sites listed yet
Study dates
Nov 2000to Sep 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

About this study

Official title: Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

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.

Being tested
Human Rotavirus Vaccine - two different formulations, Prevnar, IPOL, Infanrix, OmniHIB
Keywords
Rotavirus Gastroenteritis, Human rotavirus vaccine
Medical subject headings
Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Rotavirus Vaccine - two different formulationsBiological

    Two oral doses

  • PrevnarBiological

    Three-dose intramuscular injection (US subjects only)

  • IPOLBiological

    Two-dose intramuscular injection (US subjects only)

  • InfanrixBiological

    Three-dose intramuscular injection (US subjects only)

  • OmniHIBBiological

    Also called ActHIB

    Three-dose intramuscular injection (US subjects only)

  • PentacelBiological

    Three-dose intramuscular injection (Canada only)

Study groups in NCT00729001
Study groupRoleWhat they receive
Group AExperimentalHuman Rotavirus Vaccine - Formulation 1
Receives: Biological: Human Rotavirus Vaccine - two different formulations; Biological: Prevnar; Biological: IPOL; Biological: Infanrix; Biological: OmniHIB; Biological: Pentacel
Group BExperimentalHuman Rotavirus Vaccine - Formulation 2
Receives: Biological: Human Rotavirus Vaccine - two different formulations; Biological: Prevnar; Biological: IPOL; Biological: Infanrix; Biological: OmniHIB; Biological: Pentacel
Group CPlacebo comparatorNot described
Receives: Biological: Prevnar; Biological: IPOL; Biological: Infanrix; Biological: OmniHIB; Biological: Pentacel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with vaccine take

    Measured: Two months after the second dose

  2. Occurrence of any grade 2 or 3 fever, vomiting or diarrhea

    Measured: Within the 15-day solicited follow-up period after any dose of study vaccine.

Secondary outcomes (12)

  1. Occurrence of each type of solicited symptoms

    Measured: Within the 15-day solicited follow-up period after any dose of study vaccine

  2. Occurrence of unsolicited symptoms according to WHO classification.

    Measured: Within 42 days after dose 1 and dose 2

  3. Occurrence of serious adverse events

    Measured: Throughout the entire study period

  4. Serum rotavirus immunoglobulin A (IgA) antibody titers

    Measured: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset

  5. Rotavirus seropositivity status

    Measured: Before dose 1 and at the end of the study

  6. Vaccine take (for pilot efficacy subset only)

    Measured: 2 months after dose 1

  7. 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

    Measured: Two months after dose 2 and at the end of the study.

  8. Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

    Measured: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)

  9. Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.

    Measured: Two months after dose 2 and at the end of the study.

  10. Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.

    Measured: Two months after dose 2 and at the end of the study.

  11. Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants

    Measured: Two months after dose 2.

  12. Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)

    Measured: Two weeks after dose 2 until the end of the rotavirus season following vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2008 (estimated)
  2. Study startNov 2000
  3. Primary completionSep 2002
  4. Study completionSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00729001
Sponsor's protocol ID
444563/005
Status last verified
Sep 2016
First submitted
4 Aug 2008
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Rotavirus Vaccine - two different formulations, Prevnar and IPOL in people with Infections, Rotavirus, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with vaccine take (time frame: Two months after the second dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729001, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.

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