All Title Author
Keywords Abstract

PLOS ONE  2014 

Children Who Received PCV-10 Vaccine from a Two-Dose Vial without Preservative Are Not More Likely to Develop Injection Site Abscess Compared with Those Who Received Pentavalent (DPT-HepB-Hib) Vaccine: A Longitudinal Multi-Site Study

DOI: 10.1371/journal.pone.0097376

Full-Text   Cite this paper   Add to My Lib


Background The single dose pneumonia ten-valent vaccine has been widely used and is highly efficacious against selected strains Streptococcus pneumonia. A two-dose vial without preservative is being introduced in developing countries to reduce the cost of the vaccine. In routine settings improper immunization practice could result in microbial contamination leading to adverse events following immunization. Objective To monitor adverse events following immunization recommended for routine administration during infancy by comparing the rate of injection-site abscess between children who received PCV-10 vaccine and children who received the Pentavalent (DPT-HepB-Hib) vaccine. Methods A longitudinal population-based multi-site observational study was conducted between September 2011 and October 2012. The study was conducted in four existing Health and Demographic Surveillance sites run by public universities of Abraminch, Haramaya, Gondar and Mekelle. Adverse events following Immunization were monitored by trained data collectors. Children were identified at the time of vaccination and followed at home at 48 hour and 7 day following immunization. Incidence of abscess and relative risk with the corresponding 95% Confidence Intervals were calculated to examine the risk difference in the comparison groups. Results A total of 55, 268 PCV and 37, 480 Pentavalent (DPT-HepB-Hib) vaccinations were observed. A total of 19 adverse events following immunization, 10 abscesses and 9 deaths, were observed during the one year study period. The risk of developing abscess was not statistically different between children who received PCV-10 vaccine and those received Pentavalent (RR = 2.7, 95% CI 0.576–12.770), and between children who received the first aliquot of PCV and those received the second aliquot of PCV (RR = 1.72, 95% CI 0.485–6.091). Conclusion No significant increase in the risk of injection site abscess was observed between the injection sites of PCV-10 vaccine from a two-dose vial without preservative and pentavalent (DPT-HepB-Hib) vaccine in the first 7 days following vaccination.


[1]  Tichmann SI, Soemantri P, Behre U, Disselhoff J, Mahler H, et al. (2005) Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate Vaccine. Pediatr Infect Dis J 24: 70–77. doi: 10.1097/01.inf.0000148923.46453.48
[2]  Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ (2006) Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine 24: 4727–4736. doi: 10.1016/j.vaccine.2006.03.032
[3]  Olivier C, Belohradsky BH, Stojanov S, Bonnet E, Petersen G, et al. (2008) Immunogenicity, reactogenicity, and safety of a seven-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a fully liquid DTPa-IPV-HBV-Hib combination vaccine in healthy infants. Vaccine 25: 3142–3152. doi: 10.1016/j.vaccine.2007.11.096
[4]  Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N (2009) Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J 28: 109–118. doi: 10.1097/inf.0b013e318199f62d
[5]  Drain PK, Nelson CM, Lloyd JS (2003) Single-dose versus multi-dose vaccine vials for immunisation programmes in developing countries. Bull World Health Organ 81: 726–731.
[6]  Clements CJ, Wesselingh SL (2005) Vaccine presentations and delivery technologies -what does the future hold? Expert Rev Vaccines 4: 281–287. doi: 10.1586/14760584.4.3.281
[7]  World Health Organization (1999) Immunisation safety surveillance: guidelines for managers of immunisation programmes on reporting and investigating adverse events following immunization. Manila, Philippines: World Health Organization, Regional Office for the Western Pacific. 56 p.
[8]  Black S, Zuber PL (2009) Global trends and challenges in vaccine safety. Pediatric Health 3: 329–335. doi: 10.2217/phe.09.25
[9]  Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, et al. (2003) Surveillance for safety after immunisation: Vaccine adverse event reporting system (VAERS) – United States, 1991–2001. MMWR Surveillance Summaries 52: 1–24.
[10]  Fitzner J, Coulibaly D, Kouadio DE, Yavo JC, Loukou YG, et al. (2004) Safety of the yellow fever vaccine during the September 2001 mass vaccination campaign in Abidjan, Ivory Coast. Vaccine 23: 156–162. doi: 10.1016/j.vaccine.2004.05.018


comments powered by Disqus