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Updated: Jun 6, 2026
Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months
Matthew D Snape1, Chaam L Klinger, Elvis D Daniels
1Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Headington, United Kingdom.
Insights
The 13-valent pneumococcal conjugate vaccine (PCV13) demonstrated strong immunogenicity and was well tolerated in infants. This novel vaccine provides protection against 13 pneumococcal serotypes when administered on a 2-, 4-, and 12-month schedule.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- A novel 13-valent pneumococcal conjugate vaccine (PCV13) was developed, targeting 13 specific pneumococcal serotypes.
- PCV13 contains polysaccharides conjugated to CRM197, designed for infant immunization schedules.
Purpose of the Study:
- To evaluate the immunogenicity and safety of a 2-, 4-, and 12-month immunization schedule of PCV13 in healthy infants.
- To compare the immune responses elicited by PCV13 against those of the 7-valent pneumococcal conjugate vaccine (PCV7).
Main Methods:
- A randomized, double-blind, controlled study involving 286 healthy infants.
- Infants received PCV13 or PCV7 along with other routine childhood vaccines (MenC, DTaP-IPV-Hib).
- Specific antibody responses (serum IgG, OPA titers, MenC bactericidal assay) were measured at multiple time points.
Main Results:
- PCV13 induced high serotype-specific IgG concentrations (≥0.35 µg/mL) in >97% of recipients for most serotypes, and OPA titers (≥1:8) in ≥93% of recipients.
- Humoral immune responses to Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroup C (MenC) were comparable between PCV13 and PCV7 groups.
- Local reactions and systemic events were similar between the PCV13 and PCV7 groups, indicating good tolerability.
Conclusions:
- A 2-, 4-, and 12-month vaccination course of PCV13 is immunogenic for all 13 targeted pneumococcal serotypes.
- PCV13 was found to be well tolerated in the studied infant population.
- The study supports the efficacy and safety of PCV13 for infant immunization programs.
Background:
A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study.
Methods:
Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months.
Results:
At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ≥0.35 µg/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ≥1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ≥0.15 µg/mL (difference, 1.5%; CI, -7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ≥1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ≥2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ≥5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups.
Conclusions:
A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated.
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