A follow-up trial to assess the persistence of the immune response to the Group B Streptococcus vaccine (GBS‑NN/NN2) after a primary vaccination of healthy pregnant women, and to assess safety, reactogenicity and immunogenicity of the GBS‑NN/NN2 vaccine when administered during the follow-up as a 1 booster dose during a new pregnancy

Prevention of Group B streptoccoccus infection

Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL, m easured once a year in all participants

1. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL pre-dose, at 1 month post-dose, a t delivery, and 6 months after delivery, 2. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth, 3. In the pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL at delivery, 4. In pregnant participants who did not receive a booster dose of the GBS-NN/NN2 vaccine and their infant: The ratios of antibody concentrations (IgG) between maternal and cord blood at delivery/birth, 5. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood and at 1 month and 3 months of age, 6. In the infants born to participants who did not receive a booster dose of the GBS-NN/NN2 vaccine: Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood, 7. In all participants: Any trial procedure-related SAEs (ie, SAEs related to blood sampling) during the entire trial period, 8. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with solicited local and systemic AEs within 7 days after dosing (ie, day of dosing +6 days post-dose), 9. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with unsolicited AEs within 28 days after dosing (ie, the day of dosing +27 days post-dose), 10. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with SAEs up to 6 months after delivery, 11. In the pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of participants with AESIs up to delivery, 12. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: GA, weight, length, head circumference, and Apgar score, 13. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Proportion of infant participants with unsolicited AEs up to 1 month of age, 14. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine: Developmental milestones at 6 months of age, 15. In the infants born to participants who received a booster dose of the GBS-NN/NN2 vaccine:Proportion of infant participants with MAAEs, SAEs, and AESIs up to 6 months of age, 16. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: OPkA titres in maternal blood at 1 month post-dose and at delivery, 17. In pregnant participants who received a booster dose of the GBS-NN/NN2 vaccine and their infant: PkA titres in infant participants cord blood and at 1 month and 3 months of age

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