Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Streptococcal Infections

Treatments: Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg; Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg; Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg; Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg; Other: Saline solution; Other: saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193920

V98_08

MCC Reference n° 20100601 (Other Identifier)

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Enrollment: 380 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
• Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Exclusion criteria

• Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
• Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 6 patient groups, including a placebo group

1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg

Experimental group

Description:

Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Treatment:

Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg

2: Placebo - Sterile saline

Placebo Comparator group

Description:

Non-Pregnant Women who received two injection of saline solution.

Treatment:

Other: Saline solution

3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg

Experimental group

Description:

Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Treatment:

Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg

4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg

Experimental group

Description:

Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Treatment:

Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg

5: GBS Trivalent Vaccine - 5/5/5 µg

Experimental group

Description:

Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Treatment:

Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg

6: Placebo - Sterile saline

Placebo Comparator group

Description:

Pregnant Women who received one injection of saline solution.

Treatment:

Other: saline solution