Who is sponsoring NCT00258154?

NCT00258154 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00258154?

Interventions in NCT00258154: Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: placebo, Comparator: Infanrix(tm) Hexa.

What condition does NCT00258154 study?

NCT00258154 studies Rotavirus Disease.

Is NCT00258154 still recruiting?

NCT00258154 is currently completed. Last updated 5 October 2015.

Are results published for NCT00258154?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-10-05 · How we verify

NCT00258154

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants

Completed Phase 3 Results posted Last updated 5 October 2015

What this trial tests

Phase 3 trial testing Rotavirus Vaccine, Live, Oral, Pentavalent in Rotavirus Disease in 403 participants. Completed in 1 November 2006.

Timeline

1 February 2006

Primary endpoint
1 November 2006

1 November 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	403
Start date	1 February 2006
Primary completion	1 November 2006
Estimated completion	1 November 2006

Drugs / interventions tested

Rotavirus Vaccine, Live, Oral, Pentavalent — full drug profile →
Comparator: placebo — full drug profile →
Comparator: Infanrix(tm) Hexa — full drug profile →

Conditions studied

Rotavirus Disease — all drugs for Rotavirus Disease →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 6 Weeks to 12 Weeks, any sex, with Rotavirus Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1
Time frame: Day 1 of a 3-dose regimen
Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen
Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen
Time frame: 42 days after 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1
Time frame: Day 1 of 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen
Time frame: 42 days after a 3-dose regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen

Sponsor's own description

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Rotavirus Vaccine, Live, Oral, Pentavalent

Trials testing the same drug.

NCT04398706 — Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Tod · Phase 2 · completed
NCT03691610 — Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routin · Phase 3 · completed

Other recruiting trials for Rotavirus Disease

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00258154 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 5 October 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00258154.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing