A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
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ClinicalTrials.gov Identifier: NCT00657683 |
Recruitment Status
:
Completed
First Posted
: April 14, 2008
Last Update Posted
: December 8, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Invasive Group B Streptococcus (GBS) Disease | Biological: Monovalent GBS-CRM glycoconjugate vaccine Biological: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | May 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Monovalent GBS-CRM glycoconjugate vaccine
1 dose of GBS conjugate vaccine
|
Placebo Comparator: 2 |
Biological: Placebo
1 dose of placebo
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- To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events. [ Time Frame: 1 month ]
- To study the magnitude and durability of GBS-specific antibody responses over 12 months. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy females 18 through 40 years of age;
- have provided written informed consent after the nature of the study has been explained;
- are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
- are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator
Exclusion Criteria:
- unwilling or unable to give written informed consent to participate in the study;
- pregnant (serum pregnancy test)
- unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
- nursing (breastfeeding) mothers

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657683
Switzerland | |
Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A. | |
Ligornetto, Switzerland, 6853 |
Study Chair: | Novartis Vaccines | Novartis Vaccines |
Responsible Party: | Novartis Vaccines |
ClinicalTrials.gov Identifier: | NCT00657683 History of Changes |
Other Study ID Numbers: |
V98P1 |
First Posted: | April 14, 2008 Key Record Dates |
Last Update Posted: | December 8, 2011 |
Last Verified: | December 2011 |
Keywords provided by Novartis ( Novartis Vaccines ):
GBS GBS prevention |
Additional relevant MeSH terms:
Vaccines Immunologic Factors Physiological Effects of Drugs |