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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109343
Other study ID # V221-019
Secondary ID 2005_027
Status Completed
Phase Phase 3
First received April 27, 2005
Last updated February 11, 2015
Start date March 2006
Est. completion date September 2007

Study information

Verified date February 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.


Recruitment information / eligibility

Status Completed
Enrollment 1027
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 15 Months
Eligibility Inclusion Criteria:

- In good health

- 12 to 15 months of age

- Negative clinical history to measles, mumps, rubella, varicella and/or zoster

- Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines

- Signed consent

Exclusion Criteria:

- Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination

- Any condition resulting in depressed immunity

- Any allergy to any vaccine component as stated in the package circulars

- Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination

- History of seizure disorder

- Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days

- Recent febrile illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Comparator: ProQuad™ (V221)
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine)
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schödel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 4 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 6B 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 9V 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 14 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 18C 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 19F 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Other Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer =0.2 mcg/mL for S. Pneumoniae Serotype 23F 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer =255 mIU/mL Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline. 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone Yes
Primary Number of Participants With Postvaccination Mumps ELISA Antibody Titer =10 Ab Units/mL Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline. 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone No
Primary Number of Participants With Postvaccination Rubella ELISA Antibody Titer =10 IU/mL Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline. 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone No
Primary Number of Participants With Postvaccination Varicella Antibody Titer =1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and =5 gpELISA Units/mL Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone. No
Primary Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
Primary Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone No
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