Immune Response Induced by a Trivalent Group B strep. vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings.

• Conditions: Prophylaxis against Group B Streptococcus infection.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-020840-36-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-11
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1) Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation
2) Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
3) Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
4) Individuals who will be available for all scheduled visits (i.e. not planning to leave the area before the end of the study period).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Individuals who are unwilling and/or unable to give written informed consent to participate in the study.
2) Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
3) Individuals with any known or suspected impairment/alteration of immune function, either congenital or resulting from:
• receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 15 mg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy, Topical corticosteroids are allowed)
• receipt of immunostimulants
• receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 12 weeks prior to enrollment and for the full length of the study
Note: Anti-D Immunoglobulins given for Anti-D prophylaxis are allowed.
4) Individuals characterized as high risk” pregnancies at investigator discretion, such as those who have
? gestational diabetes
? pre-eclampsia/eclampsia,
? women at risk of pre-term labor (except positivity for vaginal Group B strep.)
? History of previous pregnancy complications including delivery of pre-term infant
? History of still-birth, late abortions and children with congenital anomalies
5) Individuals who receive any other investigational agent or investigational intervention during the course of the study.
6) Individuals with acute infection including oral temperature = 38°C are temporarily excluded. They may be enrolled once the infection has resolved (as judged by investigator).
7) HIV positive by history
8) Individuals reporting any known or suspected serious acute, chronic or progressive disease (e.g., any history of neoplasm, malignancy, including lymphoproliferative disorder, diabetes, cardiac disease, malnutrition, renal failure, autoimmune disease, HBV or HCV, blood disorders).
Note: Malignancies, highly likely to having been cured at the investigators discretion are allowed. (e.g. no relapse since 5 years post last malignancy specific treatment)
9) Individuals with bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
10) Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study (e.g. who are not able to comprehend or to follow all required study procedures for the whole period of the study).
11) Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
12) Individuals with history or any illness that, in the opinion of the investigator, might pose additional risk to subjects due to participation in the study.
13) Individuals who are part of study personnel or close family members conducting this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified