| Study | Reason for exclusion |
|---|---|
| Aristegui 1998 | Comparison of three lots of HIB: DTPa‐HBV (lot no. 16707B2) + HIB (002A44); DTPa‐HBV (16708B2) + HIB (001A41); and DTPa‐HBV (16710A2) + HIB (003A41) |
| Aristegui 2001 | Compares DTPa/HIB with DTPw + HIB as booster. No HBV. Reactogenicity and safety only |
| Bavdekar 2007 | Evaluates the immunogenicity of the HBV and HIB components and the overall safety and reactogenicity of the DTPw‐HBV/HIB vaccine. No comparison of combined and separate vaccines |
| Botet‐Asensi 2003 | DTPw/HIB vaccine compared to separate injections of DTPw+ HIB. No HBV |
| Calbo 2002 | Comparative trial to assess the reactogenicity of the DTPa vaccine + HIB and DTPw + HIB administered in single injection as a booster dose. No HBV |
| Clemens 2003 | Immunogenicity and safety of a novel DTPw/HIB Brazilian combination compared to a licensed DTPw/HIB European combination |
| Denoel 2007 | Not a RCT: report of primary and booster‐based paediatric clinical trials |
| Diaz‐Mitoma 2011 | Compares different formulas of combined vaccines: diptheria‐tetanus‐pertussis‐polio‐HIB + HBV vaccine compared to 1 of 3 double‐blind investigational formulations |
| Gatchalian 2005 | Compares 2 combined vaccines: DTPw‐HBV/HIB containing 2.5 micro PRP compared to GSK Biologicals' licensed Tritanrix HepB/Hiberix containing 10 micro PRP |
| Gentile 2011 | Assesses DTPw‐HBV‐HIB combination vaccine in infants who had or had not received a birth dose of HBV vaccine |
| Gylca 2001 | DTPa‐HBV‐IPV + HIB vaccine compared to DTPw‐IPV/HIB + HBV vaccine (diphtheria, tetanus, pertussis, polioviruses, PRP antigens + HBsAg (HBV) vaccine) |
| Halperin 2009 | Compared 4 formulations of a liquid, hexavalent DTPa‐IPV‐HIB‐HBV vaccine |
| Hla 2006 | A randomised, dose‐ranging trial to asses the combined vaccine content (no comparison to separate vaccines) |
| Hogg 2003 | Assesses the immunogenicity of oral poliomyelitis vaccine under current and possible new conditions (different objective) |
| Huang 1998 | Combined DTP/HIB and separate DTP + HIB vaccination without HBV |
| Kalies 2004 | No RCT: follow‐up of case surveillance and vaccine uptake |
| Kanra 2006 | Combined DTPw‐HBV‐HIB compared with separately administered DTPw‐HIB and HBV vaccines |
| Kilpi 2009 | Evaluates 2 commercial DTPa‐HBV‐IPV/HIB combination vaccines |
| Knuf 2006 | Hexavalent diphtheria‐tetanus‐acellular pertussis‐hepatitis B‐inactivated polio virus‐H. influenzae type b vaccine concomitantly with PCV7 (DTPa‐HBV‐IPV‐HIB and PCV7) compared with DTPa‐HBV‐IPV/HIB |
| Lagos 2005 | Comparison of Lot‐to‐Lot consistency of combined vaccine and not comparison of combined and separate vaccines |
| Lim 2007 | Comparison of combined DTPa‐IPV/HIB + HBV vaccines with DTPa‐HBV‐IPV/HIB vaccine |
| Lopez 2002 | Not a RCT: no control group |
| Madhi 2011 | Compares DTPa‐IPV‐HBV‐PRP‐T with DTPw‐HIB, HBV and OPV or DTPa‐IPV‐HBV‐PRP‐T vaccine with HBV vaccine at birth |
| Meriste 2006 | Comparison of combined DTPa‐HBV‐IPV with DTPa‐HBV and IPV separate vaccines |
| Mills 1998 | Comparison between a 5‐component pertussis combination vaccine (CPDT‐IPV/PRP‐T) to that of whole cell pertussis combination vaccine (DPT‐IPV/PRP‐T) |
| Nolan 2004 | Only data on antibody persistence (immunogenicity) of plain PRP and conjugate PRP‐T was provided |
| Pichichero 1999 | Avidity maturation of antibody to HIB after immunisation with DTPa/HIB/HBV |
| Pichichero 2007 | Compares the DTPa‐HBV‐IPV vaccine co‐administered with PCV7 and HIB vaccine to separate vaccines concurrently or staggered (delayed) administration of PCV7 vaccine |
| Poolman 2001 | Not RCT: 2 studies in Germany and USA reported to show that the nature and function of the antibody are the same in combined and separate DTPa‐HBV‐IPV/HIB vaccination |
| Saenger 2005 | 2 studies reported elsewhere, while only data of safety is provided |
| Scheifele 2005 | Evaluation of a fourth dose of DTPa‐IPV/PRP‐T and not compared with separate vaccines |
| Scheifele 2006 | Concurrently administered PCV7, DTPa‐IPV/PRP‐T and HBV compared with separate injections |
| Tichmann 2005 | Comparison of 2 combined vaccines |
| Tichmann‐Schumann 2005 | DTPa‐HBV‐IPV/HIB vaccine and 7vPn conjugate vaccine compared with the administration of the hexavalent DTPa‐HBV‐IPV/HIB vaccine given alone |
| Tregnaghi 2011 | Compares DTPa‐IPV‐HBV‐PRP‐T vaccine with Pentaxim and Engerix B Pediatrico (HBV monovalent) vaccine in infants born to HBV surface antigen seronegative mothers |
| Trollfors 2005 | Study of the effect of pertussis toxoid on the immunogenicity of DT during a trial of an Pa vaccine |
| Usonis 1999a | The target is to ensure that separate, concomitant vaccination does not interfere with the PRP response nor negatively influence the reactogenicity profiles of the vaccines when used with an Pa based combination. In the trial, HIB immunisation performed concomitantly with a candidate DTPa‐HBV‐IPV in order to compare the local reactogenicity and immunogenicity of 4 commercial HIB vaccines |
| Usonis 1999b | Evaluation of the immunogenicity and reactogenicity of a new combined DTPw‐HBV/HIB. Comparison of HIB Lot 001A44 to HIB Lot 002A41 |
| Zepp 1997 | A study of memory B‐cell induction and the immune response to the combined DTPa‐HBV‐HIB vaccine (no comparison) |
| Zepp 2004 | 2 studies report of safety and reactogenicity of infant primary immunisation with the simultaneous administration of six vaccines in a single injection (DTPa‐IPV/HIB) to the administration of the same vaccine‐antigens given as 2 separate injections with widely used licensed products |
DT: diphtheria and tetanus toxoids DTPa: diphtheria, tetanus, acellular pertussis DTPw: diphtheria, tetanus, whole cell pertussis HBV: hepatitis B virus HIB: H. influenzae type B IPV: inactivated polio virus Pa: acellular pertussis PCV7: pneumococcal 7‐valent conjugate vaccine PRP: polyribsylribitolphosphate PRP‐T: polyribsylribitolphosphate vaccine conjugated to tetanus toxoid RCT: randomised controlled trial 7vPn: pneumococcal 7‐valent conjugate vaccine