Vaksin gabungan DTP‐HBV‐HIB berbanding vaksin DTP‐HBV dan HIB yang diberi secara berasingan untuk pencegahan primer diphtheria, tetanus, pertusis, hepatitis B dan Haemophilus influenza B (HIB)
Abstract
Background
Advantages to combining childhood vaccines include reducing the number of visits, injections and patient discomfort, increasing compliance and optimising prevention. The World Health Organization (WHO) recommends that routine infant immunisation programmes include a vaccination against Haemophilus influenzae (H. influenzae) type B (HIB) in the combined diphtheria‐tetanus‐pertussis (DTP)‐hepatitis B virus (HBV) vaccination. The effectiveness and safety of the combined vaccine should be carefully and systematically assessed to ensure its acceptability by the community.
Objectives
To compare the effectiveness of combined DTP‐HBV‐HIB vaccines versus combined DTP‐HBV and separate HIB vaccinations.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1966 to week 1, November 2011), EMBASE (January 1990 to November 2011) and www.clinicaltrials.gov (up to April 2011).
Selection criteria
Randomised controlled trials (RCTs) or quasi‐RCTs comparing vaccination with any combined DTP‐HBV‐HIB vaccine, with or without three types of inactivated polio virus (IPV) or concomitant oral polio vaccine (OPV) in any dose, preparation or time schedule, compared with separate vaccines or placebo, administered to infants up to two years old.
Data collection and analysis
Two review authors independently inspected references identified by the searches and evaluated them against the inclusion criteria, extracted data and assessed the methodological quality of included trials.
Main results
Data for the primary outcome (prevention of disease) were lacking. We performed a meta‐analysis to pool the results of 20 studies with 5874 participants in an immunogenicity analysis and 5232 participants in the reactogenicity analysis. There were no data on clinical outcomes for the primary outcome (prevention of disease) and all studies used immunogenicity and reactogenicity (adverse events). The number of vaccine doses differed significantly between the studies. Heterogeneous interventions, study location, healthcare environment and combining research across disparate geographical locations, may have lead to bias. The risk of bias was unclear across most of the included studies. Comparisons found little heterogeneity. In two immunological responses the combined vaccine achieved lower responses than the separate vaccines for HIB and tetanus. No significant differences in immunogenicity were found for pertussis, diphtheria, polio and hepatitis B. Serious adverse events were comparable with mainly hospitalisation and acute bronchiolitis cases. Minor adverse events such as pain and redness were more common in children given the combined vaccine. Overall, the direction shown by the results is in favour of the DTPw (diptheria‐tetanus‐whole cell pertussis)‐HBV‐HIB vaccine rather than the DTPa (diptheria‐tetanus‐acellular pertussis)‐HBV‐HIB vaccine when compared to the separate vaccines (size of effect: risk ratio (RR) 1.43; 95% confidence interval (CI) 0.98 to 2.10, for 5269 participants).
Authors' conclusions
We could not conclude that the immune responses elicited by the combined vaccine were different from or equivalent to the separate vaccines. There was significantly less immunological response for HIB and tetanus and more local reactions in the combined injections. However, these differences rely mostly on one study each. Studies did not use an intention‐to‐treat (ITT) analysis and we were uncertain about the risk of bias in many of the studies. These results are therefore inconclusive. Studies addressing clinical end points whenever possible, using correct methodology and a large enough sample size should be conducted.
PICOs
Ringkasan bahasa mudah
Vaksin gabungan DTP‐HBV‐HIB berbanding vaksin DTP‐HBV dan HIB yang diberi secara berasingan kepada bayi‐bayi yang sihat sehingga umur dua tahun
Vaksinasi kanak‐kanak menyediakan kaedah yang berkesan untuk perlindungan terhadap penyakit. Pertubuhan Kesihatan Sedunia (WHO) mengesyorkan program imunisasi bayi rutin menyertakan vaksinasi terhadap Haemophilus influenzae (H. influenza) jenis B (HIB) dalam vaksinasi gabungan difteria‐tetanus‐pertusis (DTP)‐virus hepatitis B (HBV). Kami membandingkan vaksin gabungan DTP‐HBV‐HIB dengan vaksin DTP‐HBV dan HIB berasingan. Kajian‐kajian hanya melaporkan keimunogenan dan tindak balas vaksin.
Kami memasukkan 20 kajian dengan 5874 peserta dalam analisis keimunogenan dan 5232 peserta dalam analisis tindak balas vaksin. Dalam dua respons imunologi, vaksin gabungan memberi respons yang kurang berbanding vaksin berasingan untuk HIB dan tetanus.Kami tidak mendapati sebarang perbezaan penting dalam keimunogenan untuk pertusis‐difteria‐polio dan hepatitis B. Peristiwa buruk yang serious adalah sama. Peristiwa buruk minor lebih lazim dengan vaksin gabungan. Secara keseluruhan, tahap bukti yang disediakan oleh kajian‐kajian tersebut adalah rendah dan kami tidak boleh menyimpulkan bahawa respon imun dengan vaksin gabungan adalah setara dengan suntikan berasingan.
