Meningitis, MeningococcalPhase 3NCT00443846

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

A Phase 3 study testing RotaTeq® and NeisVac-C® in people with Meningitis, Meningococcal and 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

Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is… Read more about this study

Who is it for?: Ages 42 to 55 daysHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal, Rotavirus Infections
What is being tested?: RotaTeq® and NeisVac-C®
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: No sites listed yet
Study dates: 13 Feb 2007to 23 Oct 2007
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 42 to 55 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy infants, aged from 6 weeks through full 7 weeks,
Consent form signed by at least one parent or by the legal representative properly informed about the study,
Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Who cannot join

History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
Known or suspected impairment of immunological function,
Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
Prior administration of any rotavirus vaccine,
Prior administration of any vaccine within the 28 days prior to randomisation,

Show all 13Show fewer

Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
Clinical evidence of active gastrointestinal illness,
Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
Infants residing in a household with an immunocompromised person,
Prior receipt of a blood transfusion or blood products, including immunoglobulins.

About this study

Official title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants

Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

Conditions: Meningitis, Meningococcal, Rotavirus Infections
Being tested: RotaTeq®, NeisVac-C®
Keywords: Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.
Medical subject headings: Meningitis, Meningococcal, Rotavirus Infections

What participants receive

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

RotaTeq®Biological
Also called V260
Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
NeisVac-C®Biological
Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.

Study groups in NCT00443846
Study group	Role	What they receive
Group 1: Concomitant Administration	Experimental	Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age). Receives: Biological: RotaTeq®; Biological: NeisVac-C®
Group 2: Sequential Administration	Active comparator	Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age. Receives: Biological: RotaTeq®; Biological: NeisVac-C®

What is being measured

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

Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.
Measured: 28 days after the second dose of MCC vaccine (approximately 20 weeks)

Timeline

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

13 Feb 200723 Oct 2007

First posted6 Mar 2007 (estimated)
Study start13 Feb 2007
Primary completion4 Sep 2007
Study completion23 Oct 2007

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningitis, MeningococcalStudies 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: None (open label)
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00443846
Sponsor's protocol ID: V260-016
Other IDs: S06-ROT-304, 2006-005445-11
Status last verified: Sep 2017
First submitted: 5 Mar 2007
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Vesikari T, Karvonen A, Borrow R, Kitchin N, Baudin M, Thomas S, Fiquet A. Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine. Clin Vaccine Immunol. 2011 May;18(5):878-84. doi: 10.1128/CVI.00437-10. Epub 2011 Mar 9.
PubMed 21389149

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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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
ClinicalTrials.gov ID: NCT00443846
Acronym / sponsor ID: V260-016
Conditions: Meningitis, Meningococcal, Rotavirus Infections
Keywords: Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 Feb 2007 (actual)
Primary completion: 4 Sep 2007 (actual)
Study completion: 23 Oct 2007 (actual)
First posted: 6 Mar 2007 (estimated)
Results: Posted 20 Jun 2018

Clinical summary

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

Primary objective:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Concomitant Administration	Experimental	Biological: RotaTeq®, Biological: NeisVac-C®Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).
Group 2: Sequential Administration	Active comparator	Biological: RotaTeq®, Biological: NeisVac-C®Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.

Who may qualify

Ages: 42 to 55 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy infants, aged from 6 weeks through full 7 weeks,
Consent form signed by at least one parent or by the legal representative properly informed about the study,
Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Key exclusion criteria (13 listed)

History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
Known or suspected impairment of immunological function,
Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
Prior administration of any rotavirus vaccine,

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
RotaTeq®Also: V260Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.	Biological	Group 1: Concomitant Administration, Group 2: Sequential Administration
NeisVac-C®Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.	Biological	Group 1: Concomitant Administration, Group 2: Sequential Administration

Primary outcome

Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
Time frame: 28 days after the second dose of MCC vaccine (approximately 20 weeks)
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.

Results and safety

Results posted to the registry on 20 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Concomitant Administration	124	113
Group 2: Sequential Administration	123	117

Primary outcome: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype

Time frame: 28 days after the second dose of MCC vaccine (approximately 20 weeks). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1: Concomitant Administration n = 104	Group 2: Sequential Administration n = 106
Value	100 (96.5 to 100)	100 (96.6 to 100)

Group 1: Concomitant Administration vs Group 2: Sequential Administration: Difference (Group 1 - Group 2): 0 (95% CI -3.7 to 3.7)

Population analysed: The population analyzed was randomized participants excluding those with protocol violations that may have interfered with the immunogenicity evaluation.

Adverse events

Time frame: Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Concomitant Administration	1 of 116 (0.9%)	98 of 116 (84.5%)	Not reported
Group 2: Sequential Administration	1 of 122 (0.8%)	105 of 122 (86.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21389149Vesikari T, Karvonen A, Borrow R, Kitchin N, Baudin M, Thomas S, Fiquet A. Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine. Clin Vaccine Immunol. 2011 May;18(5):878-84. doi: 10.1128/CVI.00437-10. Epub 2011 Mar 9.

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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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RotaTeq® and NeisVac-C® in people with Meningitis, Meningococcal and 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 3 inclusion and 13 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 20 Jun 2018. 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. 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 20 Jun 2018). 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?

Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (time frame: 28 days after the second dose of MCC vaccine (approximately 20 weeks)). 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 NCT00443846, which also lists 1 linked publication.

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 20 Jun 2018.