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Completed

NCT Number: NCT00258154

V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

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.

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Key information

Conditions

Rotavirus Disease Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infant per investigator, 6 through 12 weeks of age

Exclusion criteria

  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • Known or suspected impairment of immunological function
  • Known hypersensitivity to any component of the rotavirus vaccine
  • Prior administration of any rotavirus vaccine
  • Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa
  • Any infant born from a known HBsAg-positive mother
  • Prior administration of any oral polio vaccine
  • Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study
  • Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization
  • History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
  • Clinical evidence of active gastrointestinal illness
  • Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination
  • Infants residing in a household with an immunocompromised person
  • Prior receipt of a blood transfusion or blood products
  • Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study
  • Any infant who cannot be adequately followed for safety by a contact visit
  • History of seizure disorders or prior history followed for safety by a contact visit
  • Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

Comparator: Placebo

Biological

3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

Comparator: Infanrix(tm) Hexa

Biological

3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  2. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen

  3. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Pre-dose (Day 1 of a 3-dose regimen)

    GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  4. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after in a 3-dose regimen

    GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  5. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  6. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  7. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  8. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  9. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  10. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  11. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  12. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  13. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  14. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  15. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  16. Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  17. Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  18. Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  19. Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen

  20. Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  21. Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1

  22. Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  23. Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1

  24. Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  25. Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1

  26. Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

  27. Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1

    Time frame: Predose (Day 1 of a 3-dose regimen)

    GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1

  28. Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen

    Time frame: 42 days after a 3-dose regimen

    GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Nov 24, 2005
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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