A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01003431

Enrollment

Registered

2009-10-28

Start date

2009-12-31

Completion date

2010-09-30

Last updated

2015-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis

Brief summary

This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.

Interventions

BIOLOGICALRotavirus Vaccine, Live, Oral, Pentavalent

\[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)\] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.

BIOLOGICALComparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)

Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).

BIOLOGICALComparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)

Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants

Exclusion criteria

* History of abdominal disorders, intestinal folding, or abdominal surgery * Impaired immune system * Prior administration of any rotavirus vaccine or DTwP/DTaP * Fever of \>= 38.1C (100.5F) at the time of vaccination * History of prior rotavirus infection, chronic diarrhea, or failure to thrive * Evidence of active gastrointestinal illness

Design outcomes

Primary

Measure	Time frame
Geometric Mean Titer (GMT) for Pertussis Toxoid	1 month post dose 3

Secondary

Measure	Time frame
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A	1 month post dose 3

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026