| Study | Reason for exclusion |
|---|---|
| Ambrose 2011 | Pooled analysis of safety data from 20 RCTs of LAIV |
| Ambrose 2014 | Review of evidence of effects of LAIV different disease severity. No primary data fitting inclusion criteria reported. |
| Anderson 1992 | Only serological outcomes presented. |
| Anonymous 2003 | Editorial only |
| Beare 1968 | Study participants were adults. |
| Belshe 2000b | Only serological outcomes presented. |
| Belshe 2000c | Only aggregated outcomes presented, duplicate publication of Belshe 1998 and 2000. |
| Belshe 2008 | Data from studies already included in review |
| Bergen 2004 | Outcomes only presented if statistically significantly increased or decreased risk in vaccinated group. Outcomes were presented by age group and setting. Authors declined to grant access to data from settings and age groups where outcomes were not significantly different between treatment and control. |
| Betts 1977 | Study participants were university students aged 18 to 25. |
| Beutner 1976 | Same study as Beutner 1979 (included) |
| Bichurina 1982 | No denominators presented. |
| Block 2011 | Non‐inferiority study |
| Boyce 1999 | No clinical outcomes for efficacy and safety |
| Boyce 2000 | Study population aged 18 to 40 |
| Boyer 1977 | Only serological outcomes were presented. |
| Cakir 2012 | Study design inconsistent (randomised case control study) |
| Chow 1979 | Serological study on part of study population of Beutner 1979 |
| Clements 1995 | Hepatitis B vaccine as control |
| Coles 1992 | Study population consisted of elderly and staff from nursing home. |
| Cowling 2014 | Incidence data derived from an RCT published elsewhere |
| Daubeney 1997 | High‐risk children |
| Donatelli 1998 | No control (split vaccine versus trivalent subunit‐type) |
| Eddy 1970 | Participants were healthy adult males. |
| Edwards 1994 | Placebo arm present only in the first study year, for which neither efficacy nor safety data are available. Age group is 1 to 65 years, and no data are presented for children only. |
| El'shina 1998 | Age group 18 to 23 |
| Feldman 1985 | Only serological outcomes presented. |
| Foy 1981 | No control |
| France 2004 | Case cross‐over |
| Fujieda 2008 | Same data of Fujieda 2006 (included) |
| Gaglani 2004 | Ecological study |
| Gendon 2004 | Study addresses the question of whether vaccinating children interrupts transmission to elderly. Study should be included in the elderly review. |
| Glezen 2001 | Comment only (on Hurwitz 2000a) |
| Groothuis 1994 | Study participants were children with chronic pulmonary diseases; no control. |
| Groothuis 1998 | Trial of respiratory syncytial virus vaccine |
| Gross 1977a | Only serological outcomes |
| Gross 1977b | No placebo control |
| Gross 1982 | All recipients had cystic fibrosis. |
| Gruber 1993 | Follow‐up times for safety outcomes variable within groups. Total follow‐up time not stated in Methods, refers to other papers for methodology. |
| Haba‐Rubio 2011 | Case report of cases of narcolepsy |
| Halperin 2002 | Study participants had chronic cardiac or pulmonary disorders. |
| Hambidge 2006 | Case cross‐over study |
| Hatch 1956 | No control |
| Heikkinen 2003 | Survey carried out on children younger than 13 years to determine the attack of flu virus in those having fever or respiratory infections |
| Hoskins 1973 | No placebo control; excluded because an influenza B vaccine was used as control |
| Hoskins 1979 | No control |
| Howell 1964a | Adult population |
| Howell 1964b | Adult population |
| Hrabar 1977 | Likely that more than 25% of the study participants are older than 25 years (mean 15.8; range 14.0 to 17.9); efficacy outcomes only serological |
| Hurwitz 2000a | Hepatitis A vaccine as control |
| Hurwitz 2000b | Hepatitis A vaccine as control |
| Jansen 2008 | Head‐to‐head: TIV+PCV7 vs TIV+PLA vs HBV+PLA |
| Jovanovic 1979 | Non‐experimental design |
| Jurgenssen 1978 | No placebo control |
| Just 1978 | No placebo control |
| Karron 1995 | Influenza vaccine administered with routine immunisation. |
| Kaufman 2000 | Telephone survey to estimate the compliance rate with influenza vaccination |
| King 2001 | Study included HIV‐infected groups and uninfected groups; uninfected groups excluded because trial was a cross‐over design; safety data for 1st, 2nd, and 3rd doses were pooled so could not be used (some placebo recipients would have received vaccine 4 to 5 weeks previously, and participants would be included in N for placebo and vaccine). |
| Kissling 2011a | Data already presented in Kissling 2011. |
| Kramarz 2001 | Study participants are children with asthma. |
| Kuno‐Sakai 1994 | Study participants are aged 16 to 17 years. No control |
| La Montagne 1983 | No original data presented. |
| Lauteria 1974 | Study population aged 18 to 24 years. |
| Lerman 1977 | Only serological data presented. |
| Lina 2000 | No control |
| Longini 2000 | Comment on Belshe 1998 and 2000 only |
| Luce 2001 | Cost‐effectiveness analysis based on the results of Belshe 1998 and 2000 |
| Luthardt 1979 | No placebo control |
| Madhi 2014 | Results reported in a study already included in the influenza vaccines in healthy adults review. |
| Marchisio 2002 | Study participants are children with recurrent otitis media. |
| Martin Moreno 1998 | Review |
| Maynard 1968 | No placebo control |
| McMahon 2008 | Non‐comparative study |
| Mendelman 2001 | Review |
| Monto 1970 | Participants vaccinated just before or during epidemic. Vaccine effectiveness expressed as O‐E. No numerator or denominator data reported. |
| Monto 1977 | Review |
| Morio 1994 | Only cumulative data from 3 years were reported to evaluate effectiveness. |
| Morris 1976 | Study participants are college students aged 18 to 29. |
| Muhammad 2011 | Non‐comparative study |
| Neuzil 2001 | Re‐analysis of Edwards 1994 (in which placebo arm was present only in the first study year, neither efficacy nor safety data are available) |
| Neuzil 2006 | Non‐comparative study |
| Nolan 2003 | No control (2 different commercial preparations of the same vaccine were compared) |
| Ogra 1977 | Same study as Beutner 1979 |
| Piedra 1991 | 3 studies in 1; 2 already included, the third is of uncertain provenance |
| Piedra 1993 | Safety data are given cumulatively on 3‐year study. |
| Piedra 2002b | All the data in this paper are presented in either Piedra 2002 or King 1998 (both included). |
| Quach 2003 | Analysis of factors associated with hospitalisation |
| Rimmelzwaan 2000 | Participants aged 18 to 55 years |
| Ruben 1973 | No placebo control |
| Schaad 2000 | Study population consists of children and adolescents with cystic fibrosis. |
| Scheifele 1990 | Non‐comparative studies |
| Schiff 1975 | Safety outcomes combined for first and second doses of vaccine |
| Slepushkin 1993 | Participants received vaccine or placebo depending on their age. |
| Stowe 2011 | Case series or case cross‐over |
| Sugaya 1994 | Study participants are children with moderate to severe asthma. |
| Sumaya 1977 | Only serological data are presented. |
| Van Hoecke 1996 | No control |
| Vasil'eva 1986 | No denominators presented. |
| Vasil'eva 1987 | Denominators for vaccinated and placebo groups were combined in results tables. |
| Wahlberg 2003 | Trial of Hib vaccine |
| Welty 1977a | Safety outcomes only with no placebo control |
| Welty 1977b | Safety outcomes only with no placebo control |
| Wesselius‐de 1972 | Only serological efficacy outcomes presented. |
| Wright 1976b | Data duplicated in Wright 1976a. |
| Wright 1985 | Only immune responses and viral shedding outcomes presented. |
| Wu 2010 | Efficacy cohort with inadequate follow‐up length |
| Zhilova 1986 | Study population aged 18 to 23 |
HBV: hepatitis B vaccine HBV+PLA: human hepatitis B virus + placebo Hib: Haemophilus influenzae b LAIV: live attenuated influenza vaccine O‐E: observed‐expected PCV: pneumococcal conjugate vaccine PLA: placebo RCT: randomised controlled trial TIV: trivalent influenza vaccine TIV+PCV7: trivalent influenza vaccine + pneumococcal vaccine, heptavalent TIV+PLA: trivalent influenza vaccine + placebo