Testing a vaccine in pregnant woman to protect their newborn babies from blood poisoning caused by a bacterium

A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent group B Streptococcus Vaccine in Healthy Pregnant Women

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020840-36-BE

Enrollment

100

Registered

2011-04-20

Start date

2011-08-08

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive group B streptococcus disease MedDRA version: 13.1 Level: PT Classification code 10053588 Term: Group B streptococcus neonatal sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Group B Streptococcus (Group B strep.) Trivalent Vaccine Product Code: Group B strep. vaccine Pharmaceutical Form: Powder for solution for injection Other descriptive name: Group B strep

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy pregnant women 18-40 years of age inclusive 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

Exclusion criteria: Women at risk for poor obstetrical outcome at screening such as gestational diabetes, pre-eclampsia / eclampsia, women at risk of pre-term labor, and history of previous obstetrical complications including delivery of pre-term infant

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare placental transfer of anti-group B Streptococcus CPS antibodies among infants born to vaccinated and to control mothers.;Secondary Objective: Pregnant women ? To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects 30 days post injection. ? To evaluate the kinetics of anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects at baseline, 30 days post vaccination, delivery and 3 months after delivery. Infant ? To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in infants born to vaccinated subjects at birth and 3 months of age. ? To evaluate the response to routine anti-diphtheria vaccination among infants born to vaccine and placebo vaccinated subjects at 1 month after the third routine vaccination. Safety Objectives: ? Pregnant Women: To evaluate safety and tolerability of a trivalent Group B strep. vaccine (5/5/5 µg of each glycoconjugate). ? Infants: To evaluate outcome of infants born to vaccine and placebo recipients, at birth, 3 and 6 months of age. ;Primary end point(s): Proportion (%) of maternal anti-Group B strep. CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (µg/ml) and maternal antibody level (µg/ml) at time of delivery, per each serotype.;Timepoint(s) of evaluation of this end point: At delivery	—

Measure

Time frame

Main Objective: To compare placental transfer of anti-group B Streptococcus CPS antibodies among infants born to vaccinated and to control mothers.;Secondary Objective: Pregnant women ? To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects 30 days post injection. ? To evaluate the kinetics of anti-Group B strep. CPS antibodies against vaccine serotypes in all subjects at baseline, 30 days post vaccination, delivery and 3 months after delivery. Infant ? To evaluate anti-Group B strep. CPS antibodies against vaccine serotypes in infants born to vaccinated subjects at birth and 3 months of age. ? To evaluate the response to routine anti-diphtheria vaccination among infants born to vaccine and placebo vaccinated subjects at 1 month after the third routine vaccination. Safety Objectives: ? Pregnant Women: To evaluate safety and tolerability of a trivalent Group B strep. vaccine (5/5/5 µg of each glycoconjugate). ? Infants: To evaluate outcome of infants born to vaccine and placebo recipients, at birth, 3 and 6 months of age. ;Primary end point(s): Proportion (%) of maternal anti-Group B strep. CPS antibody that is transferred to the newborn, calculated as the ratio between cord blood antibody level (µg/ml) and maternal antibody level (µg/ml) at time of delivery, per each serotype.;Timepoint(s) of evaluation of this end point: At delivery

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Secondary

Measure	Time frame
Secondary end point(s): Pregnant women: - GMC and GMR (i.e. GMC at different time points over baseline) of anti- Group B strep. CPS antibody (at study day 1 (GMC only), study day 31, at delivery, and at 3 months post delivery). - Proportion (%) showing a serotype specific serum IgG level over 1mg/mL, 3mg/mL, and 5 mg/mL) (at study day 31, at delivery, and at 3 months post delivery). - Proportion (%) showing a 2/3/4 fold rises of GMC between study day 1 and study day 31 and between study day 1 and delivery. Infants: -GMC of anti- Group B strep. CPS antibody in infants at birth (cord blood) and 3 months of age. - Proportion (%) of newborns, with anti-CPS antibodies above different thresholds (i.e. 1mg/mL, 3mg/mL, 5mg/mL) as measured at birth and 3 months of age. - GMC of anti-diphtheria antibodies in sera of infants collected at 1 month after the last routine infant immunization Safety Endpoints - Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events, and serious adverse events. Systemic and local reactogenicity will be evaluated for 7 days after vaccination. For women, all AEs will be recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study will be recorded. SAEs will be collected for the duration of the trial. Obstetrical outcomes will be included in this analysis. - Infant outcome will be monitored by physical exam at birth (including Apgar), 3 months of age and 1 month after the last routine infant immunization. The infant’s development status will be evaluated at 1 month after the last routine infant immunization by performing the Denver Developmental Screening Test II. For infants SAEs will be recorded from birth until study conclusion for the infant. ;Timepoint(s) of evaluation of this end point: - Day 1 - Day 31 - at delivery - 5 vs 7 months post delivery	—

Measure

Time frame

Secondary end point(s): Pregnant women: - GMC and GMR (i.e. GMC at different time points over baseline) of anti- Group B strep. CPS antibody (at study day 1 (GMC only), study day 31, at delivery, and at 3 months post delivery). - Proportion (%) showing a serotype specific serum IgG level over 1mg/mL, 3mg/mL, and 5 mg/mL) (at study day 31, at delivery, and at 3 months post delivery). - Proportion (%) showing a 2/3/4 fold rises of GMC between study day 1 and study day 31 and between study day 1 and delivery. Infants: -GMC of anti- Group B strep. CPS antibody in infants at birth (cord blood) and 3 months of age. - Proportion (%) of newborns, with anti-CPS antibodies above different thresholds (i.e. 1mg/mL, 3mg/mL, 5mg/mL) as measured at birth and 3 months of age. - GMC of anti-diphtheria antibodies in sera of infants collected at 1 month after the last routine infant immunization Safety Endpoints - Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events, and serious adverse events. Systemic and local reactogenicity will be evaluated for 7 days after vaccination. For women, all AEs will be recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study will be recorded. SAEs will be collected for the duration of the trial. Obstetrical outcomes will be included in this analysis. - Infant outcome will be monitored by physical exam at birth (including Apgar), 3 months of age and 1 month after the last routine infant immunization. The infant’s development status will be evaluated at 1 month after the last routine infant immunization by performing the Denver Developmental Screening Test II. For infants SAEs will be recorded from birth until study conclusion for the infant. ;Timepoint(s) of evaluation of this end point: - Day 1 - Day 31 - at delivery - 5 vs 7 months post delivery

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Countries

Belgium, Canada

Contacts

Public ContactSuzanne Jonkheer

Novartis Vaccines & Diagnostics

suzanne.jonkheer@novartis.com+31205640589

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026