Rotavirus InfectionsPhase 3NCT00092456

Consistency Lots Vaccine Study (V260-009)

A Phase 3 study testing rotavirus vaccine, live, oral, pentavalent in people with Rotavirus Infections, run by Merck Sharp & Dohme LLC.

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 study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine. Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Rotavirus Infections
What is being tested?: rotavirus vaccine, live, oral, pentavalent
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 793 participants
Where: No sites listed yet
Study dates: May 2003to Aug 2004
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Healthy infants

Who cannot join

History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
Known or suspected problems with the immune system
Fever at time of immunization
Prior administration of a rotavirus vaccine
History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

About this study

Official title: Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Conditions: Rotavirus Infections
Being tested: rotavirus vaccine, live, oral, pentavalent, Placebo
Medical subject headings: Rotavirus Infections

What participants receive

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

rotavirus vaccine, live, oral, pentavalentBiological
Also called V260, RotaTeq™
Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
PlaceboBiological
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10
weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Study groups in NCT00092456
Study group	Role	What they receive
RotaTeq™ Lot 1	Experimental	~8.81 X 10^7 IU/Dose of RotaTeq™ Receives: Biological: rotavirus vaccine, live, oral, pentavalent
RotaTeq™ Lot 2	Experimental	~8.01 X 10^7 IU/Dose of RotaTeq™ Receives: Biological: rotavirus vaccine, live, oral, pentavalent
RotaTeq™ Lot 3	Experimental	~6.91 X 10^7 IU/Dose of RotaTeq™ Receives: Biological: rotavirus vaccine, live, oral, pentavalent
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

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

Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]
Measured: 42 days following the 3rd vaccination

Timeline

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

May 2003Aug 2004

First posted27 Sep 2004 (estimated)
Study startMay 2003
Primary completionAug 2004
Study completionAug 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 793 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092456
Sponsor's protocol ID: V260-009
Other IDs: 2004_078
Status last verified: Sep 2015
First submitted: 22 Sep 2004
Last updated: 5 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Rotavirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
ClinicalTrials.gov ID: NCT00092456
Acronym / sponsor ID: V260-009
Conditions: Rotavirus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 793 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Aug 2004 (actual)
Study completion: Aug 2004 (actual)
First posted: 27 Sep 2004 (estimated)
Results: Posted 12 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
RotaTeq™ Lot 1	Experimental	Biological: rotavirus vaccine, live, oral, pentavalent~8.81 X 10^7 IU/Dose of RotaTeq™
RotaTeq™ Lot 2	Experimental	Biological: rotavirus vaccine, live, oral, pentavalent~8.01 X 10^7 IU/Dose of RotaTeq™
RotaTeq™ Lot 3	Experimental	Biological: rotavirus vaccine, live, oral, pentavalent~6.91 X 10^7 IU/Dose of RotaTeq™
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy infants

Key exclusion criteria (5 listed)

History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
Known or suspected problems with the immune system
Fever at time of immunization
Prior administration of a rotavirus vaccine
History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rotavirus vaccine, live, oral, pentavalentAlso: V260, RotaTeq™Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination	Biological	RotaTeq™ Lot 1, RotaTeq™ Lot 2, RotaTeq™ Lot 3
PlaceboPlacebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination	Biological	Placebo

Primary outcome

Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Time frame: 42 days following the 3rd vaccination
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]

Results and safety

Results posted to the registry on 12 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RotaTeq™ Lot 1	226	201
RotaTeq™ Lot 2	225	208
RotaTeq™ Lot 3	229	200
Placebo	113	97

Primary outcome: Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]

Time frame: 42 days following the 3rd vaccination. Geometric mean (95% Confidence Interval). Unit: dilution units

Measure	RotaTeq™ Lot 1 n = 226	RotaTeq™ Lot 2 n = 225	RotaTeq™ Lot 3 n = 229	Placebo n = 113
G1 SNA (dilution units)	167.9 (135.7 to 207.7)	193.2 (157.6 to 236.8)	171.0 (140.6 to 208.1)	9.3 (7.2 to 11.9)
G2 SNA (dilution units)	20.7 (17.3 to 24.7)	22.6 (19.1 to 26.8)	17.8 (15.1 to 20.9)	5.9 (5.3 to 6.6)
G3 SNA (dilution units)	18.0 (15.2 to 21.2)	18.5 (15.7 to 21.9)	14.6 (12.4 to 17.2)	9.6 (7.4 to 12.5)
G4 SNA (dilution units)	66.0 (57.0 to 76.4)	74.3 (64.4 to 85.7)	65.7 (55.6 to 77.5)	7.8 (6.5 to 9.4)
P1A[8] SNA (dilution units)	71.1 (60.0 to 84.2)	72.3 (61.4 to 85.3)	65.6 (55.0 to 78.2)	10.2 (7.6 to 13.5)

RotaTeq™ Lot 1 vs RotaTeq™ Lot 2: p <0.001, ANOVA
RotaTeq™ Lot 1 vs RotaTeq™ Lot 3: p <0.001, ANOVA
RotaTeq™ Lot 2 vs RotaTeq™ Lot 3: p <0.001, ANCOVA

Population analysed: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.

Adverse events

Time frame: Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RotaTeq™ Lot 1	4 of 226 (1.8%)	206 of 226 (91.2%)	Not reported
RotaTeq™ Lot 2	4 of 224 (1.8%)	212 of 224 (94.6%)	Not reported
RotaTeq™ Lot 3	2 of 229 (0.9%)	211 of 229 (92.1%)	Not reported
Placebo	3 of 111 (2.7%)	101 of 111 (91%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rotavirus Infections

Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
Rotavirus Infections
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Rotavirus Infection of Children
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rotavirus vaccine, live, oral, pentavalent in people with Rotavirus Infections, run by Merck Sharp & Dohme LLC.

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 1 inclusion and 5 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 5 Oct 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] (time frame: 42 days following the 3rd vaccination). 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 NCT00092456.

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 5 Oct 2015.